Temporomandibular Joint Dysfunction SyndromeNCT06141863
Temporomandibular Dysfunction in Patients With Cervical Disc Herniation
An observational study of Temporomandibular Joint Dysfunction Syndrome, run by Karadeniz Technical University at 1 site in Turkey (Türkiye).
Trial summary
Cervical spine problems are associated with temporomandibular joint (TMJ) and related muscles.The aim of the present study was to investigate temporomandibular joint dysfunction (TMD) and pain in individuals with cervical disc herniation (CDH) according to the level of neck disability. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Temporomandibular Joint Dysfunction Syndrome
- What is being tested?
- questionnaire
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2022to 30 Dec 2022
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Adult, Older adult
Study population: Individuals diagnosed with cervical disc herniation. Patients who were referred to physiotherapy after diagnosis were evaluated in terms of study suitability before starting treatment. We divided the participants into two groups based on their level of neck disability to compare their TMD.
Who may be able to join
- Diagnosed with cervical disc herniation aged between 18 and 65,
- who could read and write in Turkish
Who cannot join
- Individuals with a history of head and neck surgery, fracture, physiotherapy or medical treatment cervical or temporomandibular joint treatment within the last six months,
- presence of any inflammatory rheumatic diseases, such as ankylosing spondylitis and rheumatoid arthritis, facial paralysis, infection, advanced osteoporosis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of Temporomandibular Dysfunction in Patients With Cervical Disc Herniation
Cervical spine problems are associated with temporomandibular joint (TMJ) and related muscles.The aim of the present study was to investigate temporomandibular joint dysfunction (TMD) and pain in individuals with cervical disc herniation (CDH) according to the level of neck disability.
Read the detailed description
The study included diagnosed with cervical disc herniation. The participants were divided into two groups based on their The Neck Disability Index (NDI) score: Group 1 with no disability and mild disability and Group 2 with moderate and severe disability. Temporomandibular dysfunction and its severity, intensity of neck and temporomandibular joint pain was assessed.
- Being tested
- questionnaire
- Keywords
- Temporomandibular Joint Dysfunction Syndrome, Intervertebral Disc Displacement, Disability, Neck, Jaw
- Medical subject headings
- Temporomandibular Joint Dysfunction Syndrome, Intervertebral Disc Displacement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
questionnaireOther
Neck Disability Index, The Fonseca Anamnestic Index (FAI) and Visual Analogue Scale (VAS)
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | no disability and mild disability Receives: Other: questionnaire | |
| Group 2 | moderate and severe disability Receives: Other: questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neck Disability Index
Assessment of neck disability
Measured: one day assessment
Fonseca Anamnestic Index
Assessment of temporomandibular dysfunction
Measured: one day assessment
Secondary outcomes (1)
Visual Analogue Scale
Assessment of temporomandibular joint pain and neck pain intensity
Measured: one day assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2023
- Study start1 May 2022
- Primary completion30 Nov 2022
- Study completion30 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Temporomandibular Joint Dysfunction SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Karadeniz Technical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Turgay Altunalan, Karadeniz Technical University
- Investigators
- Turgay Altunalan, Assist Prof, Principal investigator, Karadeniz Technical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06141863
- Sponsor's protocol ID
- 6135131342/2022-28
- Status last verified
- Nov 2023
- First submitted
- 15 Nov 2023
- Last updated
- 21 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Temporomandibular Dysfunction in Patients With Cervical Disc Herniation
- ClinicalTrials.gov ID
- NCT06141863
- Acronym / sponsor ID
- 6135131342/2022-28
- Keywords
- Temporomandibular Joint Dysfunction Syndrome, Intervertebral Disc Displacement, Disability, Neck, Jaw
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Karadeniz Technical UniversityUniversity, hospital or other
- Study start
- 1 May 2022 (actual)
- Primary completion
- 30 Nov 2022 (actual)
- Study completion
- 30 Dec 2022 (actual)
- First posted
- 21 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Cervical spine problems are associated with temporomandibular joint (TMJ) and related muscles.The aim of the present study was to investigate temporomandibular joint dysfunction (TMD) and pain in individuals with cervical disc herniation (CDH) according to the level of neck disability.
Detailed description
The study included diagnosed with cervical disc herniation. The participants were divided into two groups based on their The Neck Disability Index (NDI) score: Group 1 with no disability and mild disability and Group 2 with moderate and severe disability. Temporomandibular dysfunction and its severity, intensity of neck and temporomandibular joint pain was assessed.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Other: questionnaireno disability and mild disability |
| Group 2 | – | Other: questionnairemoderate and severe disability |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Individuals diagnosed with cervical disc herniation. Patients who were referred to physiotherapy after diagnosis were evaluated in terms of study suitability before starting treatment. We divided the participants into two groups based on their level of neck disability to compare their TMD.
Key inclusion criteria (2 listed)
- Diagnosed with cervical disc herniation aged between 18 and 65,
- who could read and write in Turkish
Key exclusion criteria (2 listed)
- Individuals with a history of head and neck surgery, fracture, physiotherapy or medical treatment cervical or temporomandibular joint treatment within the last six months,
- presence of any inflammatory rheumatic diseases, such as ankylosing spondylitis and rheumatoid arthritis, facial paralysis, infection, advanced osteoporosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| questionnaireNeck Disability Index, The Fonseca Anamnestic Index (FAI) and Visual Analogue Scale (VAS) | Other | Group 1, Group 2 |
Primary outcome
Neck Disability Index
Time frame: one day assessment
Assessment of neck disability
Fonseca Anamnestic Index
Time frame: one day assessment
Assessment of temporomandibular dysfunction
1 secondary outcome
Visual Analogue Scale
Time frame: one day assessment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Turgay Altunalan, Assist Prof principal investigator
Karadeniz Technical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Temporomandibular Joint Dysfunction Syndrome, run by Karadeniz Technical University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neck Disability Index (time frame: one day assessment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2023.